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Onfi

  • Generic Name: clobazam tablets and oral suspension
  • Brand Name: Onfi

side effects drug center onfi (clobazam tablets and oral suspension) drug - patient side effects and images

 

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CONSUMER

SIDE EFFECTS

Onfi Patient Information Including Side Effects

Brand Names: Onfi, Sympazan

Generic Name: clobazam

What is clobazam (Onfi, Sympazan)?

Clobazam is a benzodiazepine that is used in combination with other medications to treat seizures caused by Lennox-Gastaut syndrome, a severe form of childhood epilepsy that also causes developmental and behavior problems.

Clobazam may also be used for purposes not listed in this medication guide.

What are the possible side effects of clobazam (Onfi, Sympazan)?

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Clobazam can slow or stop your breathing, especially if you have recently used an opioid medication, alcohol, or other drugs that can slow your breathing. A person caring for you should seek emergency medical attention if you have weak or shallow breathing, if you are hard to wake up, or if you stop breathing.

Call your doctor at once if you have:

  • severe drowsiness, feeling like you might pass out;
  • unusual changes in mood or behavior;
  • aggression, thoughts of hurting yourself; or
  • problems with balance or muscle movement.

The sedative effects of clobazam may last longer in older adults. Accidental falls are common in elderly patients who take benzodiazepines. Use caution to avoid falling or accidental injury while you are taking clobazam.

Common side effects may include:

  • constipation;
  • drowsiness, lack of energy;
  • fever; or
  • drooling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about clobazam (Onfi, Sympazan)?

Clobazam can slow or stop your breathing, especially if you have recently used an opioid medication, alcohol, or other drugs that can slow your breathing.

MISUSE OF THIS MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it.

Some people have thoughts about suicide while taking clobazam. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

Do not stop using clobazam suddenly, or you could have increased seizures or unpleasant withdrawal symptoms.

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Onfi Patient Information including How Should I Take

What should I discuss with my healthcare provider before taking clobazam (Onfi, Sympazan)?

You should not take clobazam if you are allergic to it.

Tell your doctor if you have ever had:

  • breathing problems or lung disease;
  • depression, mood problems, or suicidal thoughts or behavior;
  • a drug or alcohol addiction; or
  • liver or kidney disease.

Some people have thoughts about suicide while taking clobazam. Your doctor will need to check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

If you use clobazam while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks.

Do not start or stop taking seizure medication during pregnancy without your doctor's advice. Having a seizure during pregnancy could harm both mother and baby. Tell your doctor right away if you become pregnant.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of clobazam on the baby.

Clobazam can make hormonal birth control less effective, including birth control pills, injections, implants, skin patches, and vaginal rings. To prevent pregnancy while using clobazam, use a back-up barrier form of birth control: condom, diaphragm, cervical cap, or contraceptive sponge. Keep using birth control for at least 28 days after your last dose of clobazam.

If you are breastfeeding, tell your doctor if you notice drowsiness or feeding problems in the nursing baby.

Clobazam should not be given to a child younger than 2 years old.

How should I take clobazam (Onfi, Sympazan)?

Follow the directions on your prescription label and read all medication guides. Your doctor may occasionally change your dose. Never use clobazam in larger amounts, or for longer than prescribed. Tell your doctor if you feel an increased urge to use more of this medicine.

Never share this medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it. Selling or giving away this medicine is against the law.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

You may take clobazam with or without food.

If you cannot swallow a tablet whole, you may break it in half or crush it and mix the medicine into a spoonful of applesauce. Swallow the mixture right away without chewing. Do not save it for later use.

Shake the oral suspension (liquid) before you measure a dose. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

To use the oral film, place it on the top of your tongue. Swallow several times as the film dissolves, without drinking liquid.

Clobazam doses are based on weight in children. Your child's dose needs may change if the child gains or loses weight.

Do not stop using clobazam suddenly, even if you feel fine. Stopping suddenly may cause increased seizures or unpleasant withdrawal symptoms. Follow your doctor's instructions about tapering your dose.

Tell your doctor if your seizures get worse or you have them more often while taking clobazam.

Store at room temperature away from moisture and heat. Keep track of your medicine. You should be aware if anyone is using it improperly or without a prescription.

Onfi Patient Information including If I Miss a Dose

What happens if I miss a dose (Onfi, Sympazan)?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose (Onfi, Sympazan)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of clobazam can be fatal if you take it with alcohol, opioid medicine, or other drugs that cause drowsiness or slow your breathing.

Overdose symptoms may include extreme drowsiness or weakness, confusion, slow breathing, or loss of consciousness.

What should I avoid while taking clobazam (Onfi, Sympazan)?

Do not drink alcohol. Dangerous side effects or death could occur.

Avoid driving or hazardous activity until you know how this medicine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

What other drugs will affect clobazam (Onfi, Sympazan)?

Taking clobazam with other drugs that make you sleepy or slow your breathing can cause dangerous side effects or death. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Tell your doctor about all your other medicines, especially:

This list is not complete. Other drugs may affect clobazam, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Where can I get more information (Onfi, Sympazan)?

Your pharmacist can provide more information about clobazam.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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